Supporting adjuvant endocrine therapy (AET) adherence in breast cancer Cancer
Conditions
Interventions
This study aims to recruit a total of 512 women with breast cancer from around 25 NHS sites in the UK. Potential participants will be screened according to pre-defined criteria and approached during e
Sponsors
University of Leeds
Eligibility
Sex/Gender
Female
Age
18 Years to 120 Years
Inclusion criteria
Inclusion criteria: 1. Capacity to provide informed consent 2. Women with early stage (1-3) breast cancer according to the Tumor, Node, Metastasis (TNM)/American Joint Committee on Cancer (AJCC) staging system Note: Women being treated for a second primary breast cancer or a breast cancer local recurrence are eligible for the trial, providing at least one of the cancers is being treated with AET, and they meet all eligibility criteria. Women with bilateral breast cancer are permitted, providing at least one breast is affected by hormone receptor-positive disease 3. Aged >= 18 years old 4. Have sufficient proficiency in English to be able to adhere to all intervention components and data collection required 5. Treated with curative intent 6. Completed their hospital-based treatment (e.g., surgery, radiotherapy and/or chemotherapy) for the current breast cancer within the last 24 months. Note: Women are still eligible for the trial if they are being treated with abemaciclib or monoclonal antibody-based therapy such as trastuzumab, kadcyla, pertuzumab, and phesgo; these medications do not have to be completed within the 24 months stipulated within this criterion. (Updated 21/10/2025, previously: Completed their hospital-based treatment (e.g., surgery, radiotherapy and/or chemotherapy) for the current breast cancer within the last 12 months. Note: Women are still eligible for the trial if they are being treated with abemaciclib or monoclonal antibody-based therapy such as trastuzumab, kadcyla, pertuzumab, and phesgo; these medications do not have to be completed within the 12 months stipulated within this criterion). 7. Currently prescribed oral AET (tamoxifen, raloxifene, anastrozole, letrozole, exemestane) 8. Access to a mobile phone to receive SMS messages* 9. Access to a computer or smart device that can access the internet* *Source data for these items will be either partially or completely patient self-report.
Exclusion criteria
Exclusion criteria: 1. Stopped taking AET if it is clinically contraindicated according to clinical recommendation 2. Involved in a similar research trial where medication adherence is a primary outcome*,** 3. Currently attending psychotherapy/psycho-oncology/psychology/counselling services, for any clinical reason* 4. Need for treatment for a severe mental health disorder or crisis, which is likely to interfere with participation (e.g., active psychosis, bipolar disorder, significant issues with addiction or self-harm or expressing active suicidal ideation with active plans and intent*) 5. Auditory problems that would prevent the patient from participating in a telephone or video call, or hearing audio clips* 6. Taken part in the ROSETA Pilot trial. *Source data for these items will be either partially or completely patient self-report. **Consented to and the trial is still being delivered. Participation in another trial will not necessarily exclude a patient from participation. CTRU should be notified of any potential conflicting trials to facilitate a review of the feasibility of co-enrolment by the CI and Trial Management Group (TMG). The review will consider the methodological impact and participant burden.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the most effective intervention package for supporting adjuvant endocrine therapy (AET) adherence by using the Domains of Subjective Extent of Nonadherence (DOSE-Nonadherence) measure – collected at 12 months post-randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Outcomes (at 12 months post-randomisation): 1. Determine the most effective intervention package for: 1.1. Supporting AET adherence and persistence measured using NHS prescribing and/or dispensing data 1.2. Global quality of life (QoL) using EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) and McGill Quality of Life-Revised (MQoL-R) 1.3. Self-efficacy using Self-Efficacy for Appropriate Medication Use Scale (SEAMS) 1.4. For supporting AET adherence, considering key restraints such as cost using DOSE-Nonadherence 2. Estimate the cost of developing and delivering each intervention component using NHS Reference Costs, Personal Social Services Research Unit (PSSRU) cost data and UK Cancer Costs questionnaire Secondary Outcomes (at 4- and 8- months post-randomisation): 1. Estimate the main effects and interactions of the intervention components for: 1.1. Supporting AET adherence using DOSE-Nonadherence 1.2. Global quality of life using EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) and McGill Quality of Life-Revised (MQoL-R) 1.3. Self-efficacy using Self-Efficacy for Appropriate Medication Use Scale (SEAMS) 2. Estimate the effect of the (at 4-, 8- and 12-months post randomisation): 2.1. SMS component on habit formation using Self-Report Behavioural Automaticity Index (SRBAI) 2.2. The information leaflet on beliefs about medication using Beliefs about Medicine Questionnaire-Adjuvant Endocrine Therapy (BMQ-AET) 2.3. ACT component on psychological flexibility and distress using Multidimensional Psychological Flexibility Inventory – Short version (MPFI) and Depression, Anxiety and Stress Scale-21 (DASS-21) 2.4. Website component on symptomatic quality of life using European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30), European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-BR45 (EORTC QLQ-BR45) and European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-IL1 | — |
Countries
England, United Kingdom
Contacts
Public ContactROSETA Optimisation Trial Team
Outcome results
None listed